Info about NRP104 | ADHD Information
RADFORD, Va., Feb. 9 /PRNewswire-FirstCall/ -- New River Pharmaceuticals
Inc. (Nasdaq:
NRPH) today updated the status of its various pipeline product
candidates.
Clinical trials on the investigational new drug NRP104 are proceeding as
anticipated. Patient enrollment has been completed in the pivotal Phase 3
clinical trial evaluating NRP104, a conditionally bioreversible derivative of
d-amphetamine, in pediatric patients for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
A total of 301 patients with ADHD were enrolled in this multi-center
trial. The primary objective of this study is to assess the efficacy and
safety of NRP104 compared to placebo in the treatment of children aged 6-12
years with ADHD. "With the conclusion of enrollment, we have achieved an
important milestone in the development of NRP104," said Suma Krishnan, Vice
President, Product Development. "We now are working diligently to collect and
analyze the data in preparation for an expected NDA submission towards the end
of this year."
In addition to the aforementioned Phase 3 clinical trial, a Phase 2 study
designed to assess the efficacy and duration of action of NRP104 in children
(aged 6-12) with ADHD has been completed and the data are currently being
analyzed. A total of 52 patients with ADHD completed this multi-center study.
New River also announced that results from its dose proportionality study
on NRP104 in children (aged 6-12) with ADHD and the results from its
pharmacokinetic food/fast study on NRP104 in healthy volunteers met the
desired objectives.
New River has been in discussions with the National Institute on Drug
Abuse (NIDA) to develop a protocol for studying the use of NRP104 as a
treatment for cocaine dependence, an indication for which the U.S. Food and
Drug Administration (FDA) granted fast track status in August 2004. In the
event that NIDA is satisfied with the protocol and indicates an interest in
providing funding for this project, New River may enter into negotiations with
NIDA with respect to a Cooperative Research and Development Agreement on this
indication for NRP104. New River and Shire Pharmaceuticals Group plc, its
collaboration partner for NRP104, have not at this date determined whether
they will move forward with the development of NRP104 as a treatment for
cocaine dependence.
With regard to its other pipeline programs, New River anticipates filing
an Investigational New Drug application (IND) on NRP290, a conditionally
bioreversible hydrocodone derivative, in 2Q 2005. The company anticipates
filing an IND on NRP369, a conditionally bioreversible oxycodone derivative,
in 4Q 2005. New River is commencing a formal program to evaluate partnering
opportunities on NRP369. New River has reprioritized development of a
conditionally bioreversible hydromorphone derivative in favor of the
development of NRP369, and therefore is no longer in negotiations under the
letter of intent entered into in July 2004.
New River's discovery team is pursuing research and development on a
number of possible new drug candidates using the company's proprietary
Carrierwave(TM) technology. The company seeks to develop safer and improved
versions of widely-prescribed drugs in large and growing markets.
http://biz.yahoo.com/prnews/050217/nyth125_1.htmlHere is a link about NRP104. iT SOUNDS LIKE sHIRE IS COMING OUT WITH A NEW DRUG THAT DOES NOT HAVE ALL OF THE SIDE EFFECTS THAT ADDERALL DOES